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Summary: With the global population set to exceed 9 billion by 2050 and limited natural resources, food production needs to double if we are to provide food security. Innovation in agriculture will be central to finding ways to help farmers grow more food on less land. Crop protection products already help farmers to increase their yields per hectare and innovation in this area promises to further increase their efficacy. However, plant science companies invest significant amounts in many years of research to develop these products and without intellectual property protection, the incentive to invest in such innovation is severely diminished. Protection of safety and efficacy data along with data confidentiality is a key tool to foster this innovation. Javier Fernandez of CropLife Latin America explains the importance of protection of regulatory data and its relevance to the bid for food security. CropLife International will also be hosting a discussion on these issues in public-private development partnerships at the WTO Public Forum in Geneva later this month.

The value of innovation is hard to argue against, defined by the US Federal Trade Commission as delivering new and improved goods, services and processes that increase consumer standard of living and economic growth.1 Intellectual property operates as a driver for innovation, but remains to be fully understood and appreciated as such. Sound intellectual property regimes not only benefit particular right holders, but also society as a whole. In agriculture, they make it possible to develop innovative tools, such as crop protection products and improved plant traits, to help meet the critical challenge of feeding a growing world.

There is a strong development case for intellectual property rights, too. “Today, IP underpins between 50 percent and 70 percent of a country’s private sector gross earnings, so it is often decisive for commercial success or failure,” a recent study concluded.2 In fact, a “significant correlation between protection of rights and economic growth”3 was found in a study comprising 115 economies representing 96 percent of the world’s gross domestic product. On average, top percentile countries that honour property rights, including intellectual property protection, enjoy almost 10 times higher GDP than the lowest percentile.4

Intellectual property policy efforts have commonly focused on patents, trademarks and copyrights to spur innovation and creativity, particularly in industrialised and service-driven economies, and their acceptance and geographic scope has improved. However, developing country economies are supported by and large on agricultural or primary production and not industry and services. Far from reaching a mature stage, agriculture faces significant challenges: population growth, increasing demand for high quality and versatile food, a decreasing ratio of arable land per person and growing water scarcity, as well as a need for renewable energy sources. Innovative technologies in agriculture promise to be an important part of the solution to enable farmers to grow enough food, feed and fibre in a sustainable way.

Patents and plant variety protection are intellectual property tools instrumental to shepherd public and private investment for agricultural innovation. However, one of the plant science industry’s most important contributions to agriculture derives from the research and development of novel agrochemical technologies. There is a specific and globally accepted intellectual property instrument to bolster ongoing research in agrochemical technologies: regulatory data protection.

The significance of regulatory data protection for society is twofold: it is a paramount incentive that spurs innovation and technology transfer, translated into novel crop protection products that protect crops and improve farmers’ yields across geographies. Likewise, farmers, consumers and the environment are benefiting from safer, thoroughly-tested products that help farmers grow more food on less land.

Protection of Safety and Efficacy Data

Plant science products are among the most rigorously regulated products to ensure absence of unacceptable risks to farmers, consumers and the environment through stringent testing. Data generation necessary to demonstrate product safety and efficacy requires a plant science company to invest over 9 years in completing more than 120 studies costing approximately $200 million. In addition, these companies hold close scrutiny throughout the product lifecycle to uphold high standards in user, consumer and environmental safety.

The system of regulatory data protection is two-pronged:

1. Data protection – Data protection provides a temporary protection period that assures innovators that their proprietary data used to obtain a marketing approval will not suffer third party entrenchment in that given market. The rationale for exclusivity derives from dedication and significant investment required to perform costly, time-consuming and sophisticated studies.

The preferred mechanism adopted worldwide to protect proprietary regulatory data from unfair commercial use is a product exclusivity period of 10 years. During the exclusivity period, third parties are precluded from relying on the originator’s proprietary test data to obtain their crop protection product marketing approvals. Nonetheless, third party suppliers can enjoy equitable market participation opportunities if they (a) devote time, effort and investment to develop and file their own data; or (b) obtain licensed access to use proprietor’s data.

Conversely, deficient data exclusivity enforcement could have daunting effects. Improper reliance on originators’ proprietary data increases the possibility of substandard, copycat products reaching the marketplace that can pose unacceptable risks to health and the environment. Similarity of chemical, biological and toxicological properties between me-too and original products cannot be assumed. For instance, hazard and flammability ratings and warning symbols vary with choices of solvents; volatility is influenced by solvent choice and can impact crop safety; and a change in additives may have unforeseen health effects.

2. Data confidentiality – Data confidentiality provides protection of confidential business information housed in the regulatory dossier against disclosure throughout its tenancy with regulatory authorities.

The plant science industry commits itself to performing necessary testing and submitting results to regulatory authorities for due product assessment. However, authorities must guarantee adequate custody and traceability of regulatory data to prevent its disclosure during the temporary exclusivity period and after expiration thereof. Mismanagement of regulatory data after submission may irreversibly damage the innovator’s interest in a product supported by the scientific data. For example, retro-analysis of elements contained in a regulatory dataset can help copycat manufactures obtain innovators’ precise formulations. Thus, disclosure of information containing product blueprints would severely hinder the value of innovation.

Recently, public desire to access government-held information has spiralled, placing pressure on data confidentiality. There could be a legitimate interest to review scientific data for non-commercial research, educational reasons, criticism, review or news reporting. However, access to information should not be interpreted as an uncontrolled, free exchange, disclosure capability. A careful balance must be struck between preserving data confidentiality and satisfying legitimate interests in understanding effects associated to plant science products.

Robust, un-politicised and science-based regulatory and intellectual property regimes are policy instruments that benefit society as a whole. When an industry sector, such as crop protection, invests 7.5 percent of their sales to innovate optimal technology solutions for agriculture,5 an enabling business environment can only serve to improve sustainability and help to achieve the industry’s greater goal of feeding a growing population with dwindling natural resources. Protection of regulatory data is a tool that welcomes industry’s commitment to such social goals by providing the framework to enable and encourage innovation and investment, and countries should not refrain from its implementation.

The author is Javier Fernandez, Lawyer, CropLife Latin America

Federal Trade Commission. To Promote Innovation: The Proper Balance of Competition and Patent Law and Policy. October 2003. p. 1. [^]